MAXAIR Drug Patent Profile

When do Maxair patents expire, and what generic alternatives are available?

Maxair is a drug marketed by Bausch and is included in two NDAs.

The generic ingredient in MAXAIR is pirbuterol acetate. There are three drug master file entries for this compound. Additional details are available on the pirbuterol acetate profile page.

Summary for MAXAIR

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	1,892
DailyMed Link:	MAXAIR at DailyMed

US Patents and Regulatory Information for MAXAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	019009-001	Dec 30, 1986		DISCN	No	No
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	020014-001	Nov 30, 1992		DISCN	No	No

Expired US Patents for MAXAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	019009-001	Dec 30, 1986	3,700,681
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	020014-001	Nov 30, 1992	4,664,107
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	019009-001	Dec 30, 1986	4,175,128
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	019009-001	Dec 30, 1986	3,786,160

International Patents for MAXAIR

See the table below for patents covering MAXAIR around the world.

Country	Patent Number	Title	Estimated Expiration
France	2125309
Japan	H0548138
Belgium	778771
Japan	S5518701
Finland	52341
Germany	2952590
United Kingdom	1367669

MAXAIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MAXAIR Autohaler

Overview of MAXAIR Autohaler

MAXAIR Autohaler is a pressurized metered-dose aerosol unit designed for oral inhalation, containing pirbuterol acetate, a short-acting beta-2 adrenergic agonist. It is used to treat bronchospasm associated with asthma and other chronic obstructive pulmonary diseases (COPD)[2].

Market Context: Inhalable Drugs

The global inhalable drugs market, which includes products like MAXAIR Autohaler, is driven by several key factors:

• Increasing Incidence of Respiratory Conditions: The rising prevalence of asthma, COPD, and other respiratory diseases is a significant driver. For instance, the CDC reports that COPD affects 57 per 100,000 men and 40.5 per 100,000 women in the U.S.[1].
• Innovations in Inhalation Devices: Advances in metered-dose inhalers (MDIs) and other inhalation devices enhance the delivery and efficacy of inhalable drugs, contributing to market growth[4].

Segment Analysis

Drug Class

MAXAIR Autohaler falls under the category of short-acting bronchodilators, which is expected to hold a significant revenue share in the inhalable drugs market. This segment is crucial due to the immediate relief it provides for asthma and COPD symptoms[4].

Indication

The primary indications for MAXAIR Autohaler are asthma and COPD. These conditions are on the rise globally, fueling the demand for effective inhalable treatments. The COPD segment, in particular, is anticipated to grow due to new product launches and increasing demand for generics[1].

Patient Demographics

MAXAIR Autohaler is used across various patient demographics, including geriatric, adult, and pediatric patients. The geriatric segment is particularly significant due to the higher prevalence of COPD and asthma among older populations[1].

End-User and Distribution Channel

The product is primarily used in homecare settings but is also prescribed in hospitals. Distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies. The convenience and accessibility of these channels contribute to the market's growth[1].

Regional Outlook

North America

North America dominates the inhalable drugs market, with a significant revenue share. The region's growth is driven by the launch of new products, acquisitions, partnerships, and the high prevalence of chronic respiratory diseases. For example, the launch of generic versions of nasal sprays and inhalers, such as Mylan N.V.’s Wixela Inhub, a generic counterpart of Advair Diskus, has been instrumental in this growth[1].

Asia Pacific

The Asia Pacific region is expected to register a lucrative CAGR during the forecast period, driven by strategic partnerships and the increasing manufacturing of generic products. Partnerships like the one between Bora Pharmaceuticals Laboratories Inc. and Kyowa Pharmaceuticals Industry Co. Ltd. to manufacture generic products in Japan are indicative of this trend[1].

Financial Trajectory

Market Size and Growth

The global inhalation and nasal spray generic drugs market, which includes products like MAXAIR Autohaler, was estimated at USD 30.08 billion in 2024 and is projected to grow at a CAGR of 8.56% from 2025 to 2030. The revenue forecast for 2030 is expected to reach USD 38.4 billion[1].

Revenue Drivers

• Launch of New Products: The introduction of new generic inhalers and nasal sprays, such as the generic version of Meda Pharmaceuticals’ Dymista by Apotex Inc., drives market growth.
• Increasing Demand for Generics: The rising demand for generic versions of branded inhalers, due to their cost-effectiveness and equivalent efficacy, is a significant revenue driver[1].

Challenges and Opportunities

• Regulatory Hurdles: The pharmaceutical industry faces stringent regulatory requirements, which can impact the development and approval of new inhalable drugs. However, successful navigation of these hurdles can lead to substantial market opportunities[3].
• Generic Competition: The entry of generic competitors can significantly reduce the sales of branded drugs. For instance, when a drug loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug[3].

Key Takeaways

• Growing Demand: The increasing incidence of respiratory conditions and the need for immediate relief drive the demand for inhalable drugs like MAXAIR Autohaler.
• Innovative Devices: Advances in inhalation devices enhance the market's growth potential.
• Regional Growth: North America and the Asia Pacific region are key markets, driven by new product launches and strategic partnerships.
• Financial Growth: The market is projected to grow significantly, with a CAGR of 8.56% from 2025 to 2030.

FAQs

What is MAXAIR Autohaler used for?

MAXAIR Autohaler is used to treat bronchospasm associated with asthma and other chronic obstructive pulmonary diseases (COPD).

What are the key drivers of the inhalable drugs market?

The key drivers include the increasing incidence of respiratory conditions, innovations in inhalation devices, and the rising demand for generic versions of branded inhalers.

Which region dominates the inhalable drugs market?

North America dominates the inhalable drugs market, driven by the launch of new products, acquisitions, partnerships, and the high prevalence of chronic respiratory diseases.

What is the projected growth rate of the inhalation and nasal spray generic drugs market?

The market is projected to grow at a CAGR of 8.56% from 2025 to 2030.

How do regulatory hurdles impact the pharmaceutical industry?

Regulatory hurdles can significantly impact the development and approval of new inhalable drugs, affecting the market's growth and the financial trajectory of pharmaceutical companies.

Sources

1. Grand View Research: Inhalation And Nasal Spray Generic Drugs Market Report 2030
2. Drugs.com: Maxair Autohaler: Package Insert / Prescribing Information
3. DrugBank Blog: Investment Trends in Pharmaceutical Research
4. GlobeNewswire: Global Inhalable Drugs Market to Register Incremental Growth at a CAGR of ~6% by 2030 | DelveInsight